EU IVDR Legacy Device Deadlines after Regulation 2024/1860

1. Key takeaways

As amended by Regulation (EU) 2024/1860, legacy devices under Article 110 of the IVDR lapse on class-based deadlines: Class D until 31 December 2027, Class C until 31 December 2028, and Class B and Class A sterile until 31 December 2029. In parallel, Regulation (EU) 2023/607 deleted the sell-off provision, which means that devices lawfully placed on the market before the transitional period expires may continue to be made available until the certificate or the shelf life expires; there is no longer a single uniform cut-off date for clearing stock.

Two implications follow. Planning must distinguish the moment a device is placed on the market from the moment it is consumed at the end user, because only the former is now regulated. And the class-based end dates are meaningless for a specific product unless the earlier eligibility gateposts, the application submission and the written agreement with the notified body, have actually been met.

2. Legal basis

The table below lists the sources for the class-based lapse dates and the removal of the sell-off arrangement.

The dates are confirmed on official national authority pages because several competent authorities have published their own tabulations of the amended Article 110, and those tabulations remain the most practical reference for portfolio reviews.

3. Expert insights

Insight 1: the three dates are cut-offs for placing on the market, not for selling out.

Under Regulation (EU) 2023/607, once the sell-off clause was deleted, legacy devices lawfully placed on the market during the transition may continue to be made available or put into service until the certificate expires or the shelf life of the device ends. The critical planning node is therefore the moment the placing-on-the-market action occurs, not the point of final consumption downstream. Supply chain contracts, stocking agreements and distributor terms should be written around the placing-on-the-market date, since end-user inventory can legally outlive the transition deadline itself.

Insight 2: class-based lapse and the application submission date are two separate timetables.

The three dates in this part are the end points of the corridor; the QMS, application and written-agreement time points are the eligibility gateposts. For Class C, the application time point of 26 May 2026 and the written-agreement time point of 26 September 2026 have already passed; for Class B and Class A sterile, only 26 May 2027 and 26 September 2027 remain. If a gatepost is missed, the corridor end date no longer protects the specific product, and the transition terminates at the missed time point regardless of the class-based date.

Insight 3: certificates that expired before 9 July 2024 need a separate assessment.

According to the Commission’s question-and-answer document, where a certificate expired before the date of application of Regulation (EU) 2024/1860 (9 July 2024), it is regarded as still valid only if a written agreement with a notified body had been signed before expiry, or if the Member State competent authority had granted an exemption under Article 54(1), or had required the manufacturer to complete the conformity assessment within a time limit under Article 92(1). Exemptions granted after 9 July 2024 no longer trigger the extension. Each affected certificate therefore needs its own legal and evidence review rather than a blanket assumption of validity.

Insight 4: applying for only part of a portfolio causes early lapse of the uncovered remainder.

The Commission’s document states expressly that where the manufacturer applies for IVDR certification before the relevant time point for only part of the devices covered by the IVDD certificate or declaration of conformity, the uncovered devices do not satisfy the application condition, and their transitional period ends when the application time point expires. Combination certificate families and shared product platforms must therefore be mapped entry by entry, because a single submission covering half a family silently terminates the transition for the other half.

4. Practical recommendations

1. Maintain three countdown tables by class: D (2027-12-31), C (2028-12-31), and B and Class A sterile (2029-12-31).
2. Maintain the eligibility gatepost table alongside: QMS (2025-05-26), application submission (2025, 2026 or 2027-05-26 by class), written agreement (2025, 2026 or 2027-09-26 by class).
3. Map combination certificates entry by entry, so that a partial application does not force uncovered entries out early.
4. Write the placing-on-the-market action and its inventory nodes into the sales and supply chain processes, as the trigger conditions of the countdown.
5. Issue a separate legal and evidence assessment record for every certificate that expired before 9 July 2024.

5. Verification checklist

• □ The lapse date of every legacy device entry annotated by class (2027, 2028 or 2029-12-31)
• □ Confirmed that the sell-off provision has been deleted, with stock planned around the placing-on-the-market moment
• □ Checked whether the eligibility gateposts can still be met (the Class B and Class A sterile window closes on 2027-09-26)
• □ Combination certificates mapped entry by entry, with uncovered entries identified
• □ Certificates that expired before 2024-07-09 assessed specifically
• □ The three countdown tables subject to periodic management review (recommended monthly, as a practical estimate)

Regulatory information verified as of 29 October 2026.

GRZAN builds class-based countdown and gatepost tables for legacy IVD portfolios, reviews certificates that expired before the 2024 cut-off, and sequences placing-on-the-market actions against the amended Article 110 deadlines for the EU IVDR market. For tailored compliance support, contact info@grzanglobal.com.